MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB 10

Device Problem Obstruction of Flow (2423)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Thrombus (2101)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Citation: jewgenow p et al. Subclinical thrombus formation in bioprosthetic pulmonary valve conduits. Int j cardiol. 2019 apr 15;281 :113-118. Doi: 10. 1016/j. Ijcard. 2019. 01. 095. Epub 2019 jan 30. Earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a histopathologic analysis of explanted bioprosthetic pulmonary valve conduits for subclinical thrombus formation. All data were collected from multiple centers. The study included 47 explanted pulmonary conduits from patients with a history of congenital heart disease and concomitant pulmonary valve stenosis and/or insufficiency. The mean age of the patient population was 5. 6 years. Of the explanted conduits, 39 were medtronic products: hancock (23), contegra (7), melody (7), and freestyle (2). No serial numbers were provided. Among all patients, adverse events included: conduit explantation due to pulmonary stenosis and/or pulmonary insufficiency (observed in hancock, contegra and melody); and subclinical thrombus formation at the base of the valve sinus. It was reported that the duration from conduit implantation to conduit explantation was a mean 63 months (6 to 342 months). Based on the available information, medtronic product was directly associated with the adverse events. No additional adverse patient effects or product performance issues were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9504845
• MDR Text Key: 172260129
• Report Number: 2025587-2019-03857
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/20/2019 Patient Sequence Number: 1